ClinicalTrials.gg
Active, not recruitingNCT06870123Updated Aug 12, 2026

MINIMA Stem With DELTA TT or DELTA ST-C Study

An interventional study of TT cup and ST-C cup in Osteoarthritis, Hip, sponsored by Limacorporate S.p.a. Active, not recruiting at 1 site in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Limacorporate S.p.a (part of Enovis) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2022, registered Mar 2025).

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.

Read the detailed description

This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.

02

Conditions studied

  • Osteoarthritis, Hip

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03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's enrollment of 120 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

First submitted after Limacorporate S.p.a became part of Enovis.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Both genders
  • Any race
  • A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
  • patien willingness to partecipate and signature of form

Exclusion criteria

Exclusion Criteria:

  • local or systemic infection
  • septicaemia
  • persistent acute or chronic osteomyelitis
  • confirmed nerve or muscle lesion compromising hip joint function
  • vascular or nerve disease affecting the concerned limb
  • poor bone stock (for example due to osteoporosis) compromising the stability of the implant
  • metabolic disorders which may impair fixation and stability of the implant
  • any concomitant disease and dependence that might affect the implanted prosthsis
  • metal to implant materials
  • required revision of previous standard femoral stem
  • women of who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of throughout the entire study period
  • less than 5 years
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Other
    Minima Stem with ST-c Cup

    Minima Stem with ST-c Cup

    Device: TT cup and ST-C cup

  • Other
    Minima Stem with TT Cup

    Minima Stem with TT Cup

    Device: TT cup and ST-C cup

Interventions

  • DeviceTT cup and ST-C cup

    Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)

06

What researchers measure

Primary outcomes

  1. Harris Hip Score (HHS)

    Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.

    Time frame: Pre-operative, 3 months, 6 months, 1 year and 3 years

Secondary outcomes

  1. Harris Hip Score (HHS)

    Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.

    Time frame: 5 years

  2. Implant stability

    Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery

    Time frame: 6 months, 1 year, 3 years, 5 years after surgery

  3. Oxford Hip Score (OHS)

    Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery. The Oxford Hip Score is composed of two domains (pain and function) with six items or questions in each that are scored as follows: each question can be scored from 0 to 4, with 4 being the best outcome, producing overall scores running from 0 to 48, with 48 being the best outcome. The calculation of the total score is based on the above-mentioned scoring system, with a score reported as excellent for more than 41 points, good from 34 to 41, fair from 27 to 33 and poor for less than 27 points.

    Time frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years

  4. Forgotten Joint Score (FJS)

    Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery. The Forgotten Joint Score is a 12 item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, ptients' expectations and activity levels and finally psychosocial factors. It consist of 12 questions scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint.

    Time frame: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery

  5. Survival Rate

    Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery

    Time frame: 5 years

  6. Safety assessment

    Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.

    Time frame: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years

07

Study locations

1 site
  • The Orthopedic Clinic University Hospital Martin
    Martin, 036 59, Slovakia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Feb 2027, 60 months after the start.

Of 226 interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2025
First posted
Mar 11, 2025
StartActual
Feb 15, 2022
Primary completionEst.
Feb 15, 2027
CompletionEst.
Feb 15, 2029
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870123
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Feb 15, 2022
Primary completion
Feb 15, 2027 (estimated)
Completion
Feb 15, 2029 (estimated)
Last update
Aug 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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